Written Description: Description Must do more than Allow PHOSITA to “Envision” the Claimed Invention

Goeddel v. Sugano (Fed. Cir. 2010)

When two inventors both claim rights to a single invention, the USPTO is charged with awarding rights to the “first applicant to conceive the invention, provided that [inter alia,] the invention is duly reduced to practice, actually or constructively.” A foreign-filed patent application can constitute constructive reduction to practice “provided that the requirements of §112 are met.”

Sugano filed its original human fibroblast interferon (hFIF) patent applications in Japan in 1979 and 1980 but did not file the claims for the US continuation-at-issue until the 1990s. Meanwhile, Goeddel filed its application in June 1989. In the interference, Goeddel argued that Sugano’s original filings did not provide sufficient disclosure to satisfy the written description requirement of 35 U.S.C. §112 (with respect to the claims being litigated in the interference).

The BPAI (Board) held that Sugano’s 1980 Japanese Application constituted constructive reduction-to-practice of the claims. On appeal, however, the Federal Circuit has reversed – holding that the disputed claims failed the written description test because claimed DNA sequence used to create an hFIF amino-acid sequence was not explicitly defined by the original application.

The Board erred in ruling that priority is established if a person of skill in the art could “envision” the invention of the counts. Sugano argues that this ruling is supported by Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002) and University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 923 (Fed. Cir. 2004), but these cases do not hold that envisioning an invention not yet made is a constructive reduction to practice of that invention. In Enzo Biochem the court confirmed that depositing an actual sample may meet the written description requirement when science is not capable of a complete written description. Enzo Biochem, 323 F.3d at 970. In University of Rochester the court held that the description of the COX-2 enzyme did not also serve to describe all unknown compounds capable of inhibiting the enzyme. University of Rochester, 358 F.3d at 926-27. Precedent in evolving science is attuned to the state of the science, but remains bound by the requirement of showing “that the inventor actually invented the invention claimed.” Bradford, 603 F.3d at 1269; see Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993).

Sugano had argued that the specific DNA sequence coding for the amino acids was not necessary because a person of skill in the art could have identified the sequence and therefore, it was “unnecessary to spell out every detail of the invention in the specification.” The appellate panel rejected that argument – holding that the DNA itself should have been identified since the DNA sequence was claimed.

Notes:

  • Genentech owns Goeddel’s rights while the Japanese Foundation for Cancer Research owns Sugano’s rights. (Schering is a licensee).

7 thoughts on “Written Description: Description Must do more than Allow PHOSITA to “Envision” the Claimed Invention

  1. I agree with the holding of this case. In fact, I think it is becoming pretty established case law that enabling or showing possession requires more than filing a disclosure that makes something obvious.

    I do, however, wonder if Goeddel won the battle only to lose the war. I could see an examiner putting forth a fairly strong obviousness rejection based on Sugano’s Japanese Patent and the Knight article against Goeddel’s application. This observation, of course, is made without the detail knowledge of the case and invention held by Goeddel’s patent attorney. She/He may have a strong response prepared against such a rejection. It could also be that the goal of the interference was just to take the patent away from Sugano so that Genentech is free to practice the invention in the U.S.

  2. Because I’m paranoid about Examiners misinterpreting and overreacting to this case, I just want to provide the following reminder:

    MPEP 2163.02
    … the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. … The subject matter of the claim need not be described literally (i.e., using the same terms or in haec verba) in order for the disclosure to satisfy the description requirement.

  3. “I predict that some Examiner somewhere will inappropriately try to use this case to justify 112ing a claim amendment for lack of written description in the basis that the precise language in the amended claim is not found in the written description, regardless of whether the description and the figures, taken together enablingly disclose the claimed subject matter, as amended.”

    Well I have to admit that just based on D’s summary I was beginning to wonder if that was what they were trying to get at here. On the whole it doesn’t seem that way, and it looks like MM is trying to say that the decision is a good bit more complicated as well.

    “Seems like a reasonable conclusion, given these facts. I wouldn’t worry too much about Examiner’s citing this case willy-nilly, TINLA.”

    On the whole I’d agree.

    “Had the mature protein sequence been expressly disclosed by Sugano as of the critical date, then this case would be troubling.”

    That is what I was thinking was going on here. They didn’t give the sequence so there was no way for them to have WD at the appropriate date.

  4. The key language from the case:

    Sugano does not dispute that the Japanese Application does not explicitly show a DNA encoding mature hFIF or suggest using such DNA to encode mature hFIF without the presequence….

    The Japanese Application does not describe mature hFIF and does not describe the DNA coding for mature hFIF unaccompanied by the presequence. Sugano described its invention, in the initial Japanese Application, as the recombinant production of the 187 amino acid precursor, using a gene that encompasses “at least the entire coding region.” Section 112, in the context of interference priority, requires that the subject matter of the counts be described sufficiently to show that the appli-cant was in possession of the invention. That a modified gene encoding the 166 amino acid protein could have been “envisioned” does not establish constructive reduction to practice of the modified gene.

    Seems like a reasonable conclusion, given these facts. I wouldn’t worry too much about Examiner’s citing this case willy-nilly, TINLA.

    I do think that Dennis’ summary skims over some of the important facts, particularly the fact that only was the DNA sequence not disclosed but the mature protein sequence was also not disclosed. Had the mature protein sequence been expressly disclosed by Sugano as of the critical date, then this case would be troubling. As it stands, however: no big deal.

  5. I predict that some Examiner somewhere will inappropriately try to use this case to justify 112ing a claim amendment for lack of written description in the basis that the precise language in the amended claim is not found in the written description, regardless of whether the description and the figures, taken together enablingly disclose the claimed subject matter, as amended.

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